Durapore 0.45 μm Hydrophilic Filters

Transcription

1 Lenntech Tel Fax Data Sheet Durapore.4 μm Hydrophilic Filters The superior solution for extending the life of downstream sterilizing ilters by removing colloidal and particulate contaminants Hydrophilic.4 μm Durapore polyvinylidene luoride (PVDF) membrane provides low protein binding, high low rates and high throughputs. Durapore.4 μm membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-iber releasing properties. Durapore.4 μm hydrophilic ilters remove particles and microorganisms from aqueous liquid streams. These ilters are ideally suited for large volume parenteral or ophthalmics manufacturing, where preiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized. Benefits Low protein binding membrane yields high protein recovery with minimal loss of valuable product Superior membrane for iltration processes requiring high low rates and throughputs Ideal for bioburden reduction before inal sterilization Ideal for designing scalable solutions from bench top to full-scale manufacturing Membrane Types Durapore hydrophilic.4 μm with preilter.4 μm without preilter Filter Formats OptiScale small scale disposable capsule ilters Millipak low-volume capsule ilters Opticap XL disposable capsule ilters Cartridge ilters

2 Regulatory Compliance Filters with hydrophilic Durapore membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 91 Quality Systems Standard and are shipped with a Certiicate of Quality. Each Millipak, Opticap XL and cartridge ilter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements. For traceability and easy identiication, each device is marked with the product name and identifying characteristics. Multiple Formats Available Hydrophilic Durapore membranes are available in four formats and multiple conigurations that vary by iltration area and type of inlet/outlet connection. We have a format to meet your application needs. OptiScale Process Development Screening Tool OptiScale disposable capsule ilters provide a convenient small-volume option for process screening and scaling. These drop in ilters are ideal for evaluating biopharmaceuticals. OptiScale capsule ilters offer speed-to-market strategies for eficiently developing compounds and biotherapeutics. OptiScale Filters The OptiScale disposable capsule is ideally suited for process development and screening. OptiScale capsules are faster and easier to set-up than conventional 2 mm and 47 mm discs. Millipak Low-Volume Capsule Filters Millipak ilters with.4 μm hydrophilic Durapore membranes are uniquely designed for the removal of particles and microorganisms. The stacked disc design allows minimal hold-up volume and no particle shedding, making Millipak units ideally suited for high value added applications. Each Millipak ilter is integrity tested during the manufacturing process. Millipak Filters Millipak ilters are available in two different stack sizes. Adjustable, easy-to-turn, upstream vents and drain valves with hose b connections allow for easy process control.

3 Opticap XL Disposable Capsule Filters Opticap XL 2, 4, and 1 disposable capsule ilters with.4 μm hydrophilic Durapore membrane are available in multiple iltration areas, providing an optimal choice for every application. Each Opticap XL capsule is integrity tested during the manufacturing process. The patented Opticap XL capsule design allows unparalleled thermal and hydraulic stress resistance in a disposable ilter, resulting in reliability, high conidence in the sterilization process and improved cleanliness. The unique capsule design with pleated Durapore membrane minimizes hold-up volume and reduces production losses. Convenient and Easy to Use Opticap XL capsule ilters eliminate the time and the expense associated with assembling, cleaning, and validating stainless steel housings. Adjustable, easy-to-turn upstream vents and drain valves with O-ring seals and hose b connections allow for easy process control. Other ease-of-use features include low directional arrows and ribbed edges for easy gripping even with gloved hands. The Right Size A wide range of iltration areas is available to it all of your application needs, and allow easy scale-up of your small volume iltration steps to larger, full-scale iltration processes. Opticap XL Filters The Right Connections Self-contained and disposable, Opticap XL capsule ilters are supplied with a choice of inlet and outlet connections to optimize your iltration process, including sanitary langes that provide a higher low rate, fractional sanitary langes, and hose bs. Cartridge Filters Hydrophilic Durapore cartridge ilters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Each Durapore cartridge ilter is integrity tested during the manufacturing process. A variety of connections are offered to meet your application and housing requirements. Cartridge Filters

4 Specifications Nominal Dimensions Maximum length: OptiScale 2 Capsules OptiScale 47 Capsules Millipak 1 Millipak 2 39 mm (1.2 in.) with female Luer-Lok inlet/male luer slip outlet 82 mm (3.24 in.) with flange inlet/ hose b outlet; 74 mm (2.91 in.) with flange inlet/ flange outlet; 94 mm (3.7 in.) with hose b inlet/hose b outlet 13 cm (.1 in.) 1. cm (6.1 in.) Body diameter: 31 mm (1.21 in.) 69 mm (2.7 in.) 7.6 cm (3. in.) 7.6 cm (3. in.) Weight:.19 oz (. g) 2.3 oz (67 g) Filtration Area 3. cm cm 2 cm 2 (.4 ft 2 ) 1 cm 2 (1.8 ft 2 ) Materials of Construction Filter membrane: Hydrophilic PVDF Hydrophilic PVDF Hydrophilic polyvinylidene fluoride (PVDF) Structural components: Polycarbonate Polycarbonate Polycarbonate Supports: Polypropylene Polypropylene Polycarbonate Vent caps: Polypropylene Polyvinylidene fluoride (PVDF) Polyvinylidene fluoride (PVDF) Internal seal rings: Fluoroelastomers Fluoroelastomers Housing Vent Capped vent with female Luer Adjustable vent with male Luer slip and female Luer-Lok connections on inlet side of device. connections on inlet side of device. Maximum Inlet Pressure 4.1 (6 psi) at 2 C. (8 psi) at 2 C.2 (7 psi) at 2 C Maximum Differential Pressure Forward: 4.1 (6 psi) at 2 C. (8 psig) at 2 C 4.1 (6 ) at 2 C, 1.7 (2 ) at 8 C, 34 m ( ) at 123 C Reverse: ( psi).7 (1 psig) at 2 C 69 m (1 ) at 2 C Bubble Point at 23 C 179 m (26 psig) air with water Gravimetric Extractables After autoclaving and a 24 hour soak in ASTM Type 1 reagent grade water at controlled room temperature: 2. mg. mg Oxidizable Substances Meets the requirements of the USP Oxidizable Substance for Sterile Water for Filtration Test after a water flush of: 1 ml. 2 ml 2 ml Bacterial Endotoxin Aqueous extraction contains <.2 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test after a WFI flush of 1 ml. Aqueous extraction contains <. EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. Sterilization May be autoclaved for 1 cycle of 6 minutes at 123 C May be autoclaved for 3 cycles of 6 minutes at 123 C. May be autoclaved for 3 cycles of 9 minutes at 123 C. Capable of 4 kilogray (4. Megarad) gamma exposure. (Cannot be steam sterilized in-line.) Good Manufacturing Practices These products are manufactured in a facility which adheres to Good Manfacturing Practices. Non-Fiber Releasing Durapore membrane meets the criteria for a non-fiber releasing filter; defined in 21 CFR 21.3 (b) (6). Component Material Toxicity Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters meet the requirements of the current USP <88> Safety Test. Indirect Food Additive Durapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR

5 Specifications (continued) Opticap XL 2 Opticap XL 4 Opticap XL Opticap XL 1 Cartridge (per 1-inch element) Nominal Dimensions Maximum length: 14.2 cm (.6 in.) 19.6 cm (7.7 in.) 21.6 cm (8. in.) 33. cm (13.2 in.) Body diameter: 8.4 cm (3.3 in.) 8.4 cm (3.3 in.) 1.7 cm (4.2 in.) 1.7 cm (4.2 in.) 6.9 cm (2.7 in.) Filtration Area 9 m 2 (.93 ft 2 ).19 m 2 (2.9 ft 2 ).3 m 2 (3.7 ft 2 ).69 m 2 (7.4 ft 2 ).69 m 2 (7.4 ft 2 ) Materials of Construction Filter membrane: Hydrophilic PVDF Hydrophilic PVDF Prefilter Media Mixed esters of Mixed esters of cellulose cellulose Film edge: Polypropylene Supports: Polypropylene Polypropylene Structural components: Polypropylene Polypropylene Vent O-rings: Silicone O-rings: Silicone Silicone Vent/Drain ¼ in. hose b with double O-ring seal Maximum Inlet Pressure. (8 psi) at 23 C 2.8 (4 psi) at 6 C 1. (1 psi) at 8 C Maximum Differential Pressure Forward:. (8 ) at 2 C (with prefilter). (8 ) at 2 C 1. (1 ) at 8 C (with prefilter) 1.8 (2 ) at 8 C 3.4 ( ) at 2 C (without prefilter) 34 m ( ) at 13 C Reverse: 3.4 ( ) at 2 C, intermittent 3. ( ) at 2 C, intermittent Bubble Point at 23 C 193 m (28 psig) air with water Air Diffusion Through a water wet membrane at ambient temperature: Through a water wet membrane at 4. cc/min 7. cc/min 1 cc/min 23 C at 1. (22 psi): 1 cc/mm Gravimetric Extractables After autoclaving and a 24 hour soak in ASTM Type 1 reagent grade water at controlled room temperature: With prefilter mg 4 mg Without prefilter 1 mg 1 mg 1 mg 2 mg 2 mg Oxidizable Substances After autoclaving and a 24 hour soak in ASTM Type 1 reagent grade water at controlled room temperature: ml ml ml 1 ml 1 ml Bacterial Endotoxin Aqueous extraction contains <. EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. Sterilization With prefilter May be autoclaved for 3 cycles of 6 minutes at 121 C. Cannot be steam sterilized in-line. May be autoclaved for 1 cycles of 6 minutes at 121 C; steam sterilized for 1 cycles of 3 minutes at 121 C; or hot water sanitized for 3 cycles of 3 minutes at 8 C. Without prefilter May be autoclaved for 3 cycles of 6 minutes at 126 C. Cannot be steam sterilized in-line. May be autoclaved for 3 cycles of 6 minutes at 126 C; steam sterilized for 3 cycles of 3 minutes at 13 C; or hot water sanitized for 3 cycles of 3 minutes at 8 C. Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. Non-Fiber Releasing Durapore membrane meets the criteria for a non-fiber releasing filter as defined in 21 CFR 21.3 (b) (6). Component Material Toxicity Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore Filters are non-toxic per the current USP <88> Safety Test. Indirect Food Additive Durapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR All component materials meet the requirements of the EU framework regulation [193/24/EC] regarding materials and articles intended to contact food. European Pressure Equipment Directive We certify certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May This product has been classified under Article 3 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 3 of this Pressure Equipment Directive, this product does not bear the CE mark.

6 Typical Clean Water Flow Rates Millipak 1/2 Filter with.4 μm Durapore Membrane (MPHL) MPHL1_C_3 MPHL2_C_ Opticap XL 2 Capsule Filters.4 μm Durapore Membrane without prefilter (KPHL) TH FH Opticap XL 4 Capsule Filters.4 μm Durapore Membrane without prefilter (KPHL) TH FH Opticap XL Capsule Filters.4 μm Durapore Membrane without prefilter (KPHL) Opticap XL 1 Capsule Filters.4 μm Durapore Membrane without prefilter (KPHL) Opticap XL 1 Capsule Filters.4 μm Durapore Membrane with prefilter (KVHL) μm Hydrophilic Durapore Cartridge without prefilter (CVHL PP) inch 2-inch 3-inch μm Hydrophilic Durapore Cartridge with prefilter (CVHL TP) inch 2-inch 3-inch Legends Refer to Capsule Connection Type = 38 mm (1½ in.) Sanitary Flange Inlet and Outlet = 19 mm (¾ in.) Sanitary Flange Inlet and Outlet = 14 mm ( 9 / 16 in.) Hose Barb Inlet and Outlet TH = 38 mm (1½ in.) Sanitary Flange Inlet and 14 mm ( 9 / 16 in.) Hose Barb Outlet FH = 19 mm (¾ in.) Sanitary Flange Inlet and 14 mm ( 9 / 16 in.) Hose Barb Outlet 6

7 Ordering Information OptiScale Capsule Filters S V H L A OptiScale Capsule Filter Membrane Type V = Durapore Millipak Capsule Filters May be Autoclaved Pore Size HL =.4 μm (not available with prefilter) Disc Size 2 = 2 mm 47 = 47 mm Quantity per Package 3 = 3/pk 6 = 6/pk Connection Type = 6 mm (1 4 in.) Hose Barb Inlet and Outlet = 19 mm (3 4 in.) Sanitary Flange Inlet and Outlet FH = 19 mm (3 4 in.) Sanitary Flange Inlet and 6 mm (1 4 in.) Hose Barb Outlet NB = Female Luer-Lok Inlet/Male Luer-Lok Outlet M P H L 3 Millipak Capsule Filter Millipak Cartridge Filter Series 1C = Millipak 1, Non-sterile 2C = Millipak 2, Non-sterile Quantity per Package 3 = 3/pk Membrane Pore Size HL = Durapore.4 μm (not available with prefilter) Connection Type A = 14 mm ( 9 / 16 in.) Hose Barb and Outlet B = 6 mm (¼ in.) NPTM and Outlet F = 19 mm (¾ in.) Sanitary Flange Inlet and Outlet L = 38 mm (1½ in.) Sanitary Flange Inlet and Outlet Opticap XL Capsule Filters K H L A Opticap XL Capsule Filter Pore Size HL =.4 μm May be Autoclaved Quantity per Package 1 = 1/pk ( and 1 only) 3 = 3/pk (2 and 4 only) Membrane Type V = Durapore with prefilter (1 only) P = Durapore without prefilter Capsule Size 2 = Opticap XL 2 4 = Opticap XL 4 = Opticap XL 1 = Opticap XL 1 Connection Type = 38 mm (11 2 in.) Sanitary Flange Inlet and Outlet = 19 mm (3 4 in.) Sanitary Flange Inlet and Outlet = 14 mm (9 16 in.) Hose Barb Inlet and Outlet TH = 38 mm (11 2 in.) Sanitary Flange Inlet and 14 mm (9 16 in.) Hose Barb Outlet (2 and 4 only) FH = 19 mm (3 4 in.) Sanitary Flange Inlet and 14 mm (9 16 in.) Hose Barb Outlet (2 and 4 only) 7

8 Ordering Information Cartridge Filters C V H L Cartridge Filter Membrane Type V = Durapore Pore Size HL =.4 μm Cartridge Code = (2-222) O-ring = (2-222) O-ring with spear 7 = (2-226) O-ring with locking tab and spear TP = With prefilter PP = Without prefilter Cartridge Length = -inch (Code and 7 only without prefilter) 1 = 1-inch 2 = 2-inch 3 = 3-inch 4 = 4-inch (Code 7 only) Quantity per Package 1 = 1/pk (-inch only) 3 = 3/pk Lenntech bv Rotterdamseweg 42m 2629 Delft The Netherlands [email protected] Tel Fax Merck Millipore and the M logo are trademarks of Merck KGaA, Darmstadt, Germany. Durapore, Opticap, OptiScale and Millipak are registered trademarks of Merck KGaA, Darmstadt, Germany. ISO is a registered trademark of the International Organization for Standardization. ASTM is a registered trademark of American Society for Testing and Materials. ATCC is a registered trademark of American Type Culture Collection. Luer-Lok is a trademark of Becton Dickinson and Company. Lit No. DS1EN Rev. D DP SBU /212 Printed in the USA. 212 EMD Millipore Corporation, Billerica, MA. All rights reserved.

9 Durapore 4 Hydrophilic Filters SVHLA23 MPHL1CA3 KPHLA23 CVHL1TP3 SVHLA26 MPHL1CB3 KPHLA23 CVHL2TP3 SVHLA23 MPHL1CF3 KPHLA23 CVHL3TP3 SVHLA26 MPHL1CL3 KPHLA2TH3 CVHL1PP3 SVHLA2FH3 MPHL2CA3 KPHLA2FH3 CVHL2PP3 SVHLA2FH6 MPHL2CB3 KPHLA43 CVHL3PP3 SVHLA2NB3 MPHL2CF3 KPHLA43 CVHL1TP3 SVHLA2NB6 MPHL2CL3 KPHLA43 CVHL2TP3 SVHLA473 KPHLA4TH3 CVHL3TP3 SVHLA476 KPHLA4FH3 CVHL1PP3 SVHLA473 KPHLA1 CVHL2PP3 SVHLA476 KPHLA1 CVHL3PP3 SVHLA47FH3 KPHLA1 CVHL74TP3 SVHLA47FH6 KVHLA11 CVHL74PP3 SVHLA47NB3 KVHLA11 CVHLTP1 SVHLA47NB6 KVHLA11 CVHLTP1 CVHLPP1 CVHLPP1 Lenntech B.V. T F [email protected]